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United States · US · US:68788-8890_a03d33dc-a84c-4ab7-88a8-77333bfcb8e7
Cetirizine Hydrochloride Oral Solution
Orange BookUNIISPLATC R06AE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPreferred Pharmaceuticals Inc.
CountryUS (United States)
ATC codeR06AE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc116878888901120 mL in 1 BOTTLE (68788-8890-1)
Annotations
UNII (FDA Substance ID)
64O047KTOA
CETIRIZINE HYDROCHLORIDE
RxCUI 203150
Orange Book
A078870
AA
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "64O047KTOA",
"rxcui": "203150",
"inchikey": "PGLIUCLTXOYQMV-UHFFFAOYSA-N",
"display_name": "CETIRIZINE HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"817d07cf-5e31-421f-9e95-943bae01f5b0": {
"match": "brand_token",
"title": "CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SANDOZ INC]",
"spl_version": "8",
"published_date": "2026-06-01"
}
},
"productid": "68788-8890_a03d33dc-a84c-4ab7-88a8-77333bfcb8e7",
"productndc": "68788-8890",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "078870",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "5MG/5ML",
"product_no": "001",
"approval_date": "Apr 27, 2009"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CETIRIZINE HYDROCHLORIDE",
"proprietary_name": "Cetirizine Hydrochloride Oral Solution",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA078870",
"marketing_category": "ANDA",
"nonproprietary_name": "Cetirizine Hydrochloride Oral Solution",
"start_marketing_date": "20250627",
"active_numerator_strength": "1"
}Related drugs
Other records sharing ATC code R06AE.
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